FDA recalls blood pressure, heart failure medications after cancer-causing agents found

Leslie Hanson
July 17, 2018

NDMA, which was found in the valsartan products, could cause cancer, according to lab tests.

The U.S. Food and Drug Administration conducts a voluntary recall of several drugs used to treat high blood pressure and heart conditions due to active ingredient valsartan.

The recalled finished products in the USA include all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai's US subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide (HCTZ) made by Teva and Solco.

It was not immediately clear from FDA's announcement whether these companies are in a way connected to Zhejiang Huahai Pharmaceuticals. As of today, it operates in 22 countries across the globe.

Windsor Regional Hospital is asking patients to continue taking their heart medications prescribed by their doctor, even though an ingredient may have been recalled by the manufacturer. "This is why we've asked these companies to take immediate action to protect patients", explained Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.

But not all valsartan products are impacted.

If a patient is taking one of the recalled medicines listed below, they should follow the recall instructions provided by the specific company. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", Commissioner Dr. Scott Gottlieb said Friday. This chemical may also be unintentionally produced during chemical reactions. Previous trials with animals showed NDMA can trigger the growth of tumors in the liver, kidney, and respiratory tract. The drug contains NDMA, which has been classified as a "probable human carcinogen", which means it could cause cancer.

The FDA is continuing to investigate the issue and will add more information as it becomes available. The agency said its drug shortages team is also trying to ensure an adequate supply of unaffected alternatives.

Earlier this month, European authorities recalled drugs that had valsartan that were supplied by a Chinese drugmaker over concerns they may contain NDMA, as reported by Medscape Medical News.

Other reports by Iphone Fresh

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